A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
NCT ID: NCT02409186
Last Updated: 2016-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2015-03-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nimotuzumab plus chemoradiotherapy
Nimotuzumab：400mg/w，d1, week 1-7 Paclitaxel：45mg/m2, d1, week 1-7 Cisplatin：20mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
Nimotuzumab
400mg/w，d1, week 1-7
radiotherapy
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
chemoradiotherapy Paclitaxel
45 mg/m2, d1, week 1-7
chemoradiotherapy Cisplatin
20 mg/m2, d1, week 1-7
placebo plus chemoradiotherapy
placebo：400mg/w，d1, week 1-7 Paclitaxel：45 mg/m2, d1, week 1-7 Cisplatin：20 mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
radiotherapy
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
chemoradiotherapy Paclitaxel
45 mg/m2, d1, week 1-7
chemoradiotherapy Cisplatin
20 mg/m2, d1, week 1-7
placebo
400mg/w，d1, week 1-7
Interventions
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Nimotuzumab
400mg/w，d1, week 1-7
radiotherapy
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
chemoradiotherapy Paclitaxel
45 mg/m2, d1, week 1-7
chemoradiotherapy Cisplatin
20 mg/m2, d1, week 1-7
placebo
400mg/w，d1, week 1-7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. age：18-70 years
3. Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System，2009，Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
4. The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
5. Eastern Cooperative Oncology Group（ECOG）Performance status of 0-1
6. Possible semi-liquid diet
7. If there is a risk of pregnancy, male and female subjects must be effective contraception during treatment
8. Normal bone marrow reserve: neutrophil (ANC) count≥1500/mm3,platelet count≥100,000 /mm3, hemoglobin≥5.6mmol/L(9g/dL)
9. Normal renal function: serum creatinine≤1.5mg/dl and/or calculated creatinine clearance≥ 60ml/min
10. Normal hepatic function: bilirubin level≤1.5×ULN, alanine aminotransferase aspartate transaminase（ASAT）\& ALST≤1.5×ULN
11. Subjects tumor tissue available for the relevant biomarker detection
Exclusion Criteria
2. Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor（VEGF）therapy or EGFR-pathway targeting therapy not indicated in this study protocol
3. Multiple primary carcinomas of the esophagus
4. Pregnancy (confirmed by urine β-HCG) or lactation period
5. Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
6. There are obvious esophageal ulcers, chest and back more than moderate pain, symptoms of esophageal perforation
7. Unable to comprehend the study requirements or who are not likely to comply with the study requirements
8. Patients with distant metastasis
9. Patients with other malignant disease, except for curable non-melanoma skin cancer, cervical carcinoma in situ or malignant disease cure for≥5 years
10. Known grade 3 or 4 allergic reaction to any of the study treatment
11. Peripheral neuropathy \> grade 1
12. Participation in another clinical study within the past 30 days
13. Significant disease which, in the investigator's opinion, would exclude the patient from the study
18 Years
70 Years
ALL
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Jinming Yu
President
Principal Investigators
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Jinming Yu, Ph.D, M.D
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Xue Meng, Ph.D, M.D
Role: STUDY_DIRECTOR
Shandong Cancer Hospital and Institute
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
The Guangxi Zhuang Autonomous Region Cancer Hospita
Nanning, Guangxi, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
Fourth Hospital of Hebei Medical University Tumor
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Dai Chunhua, PhD
Role: primary
References
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Meng X, Zheng A, Wang J, Wu X, Li G, Zhu J, Ma H, Zhu X, Shi A, Dai C, Yan S, Wang B, Qu Z, Han C, Sun X, Ye M, Fan R, Huerxidan N, Wang X, Yu J. Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial. Br J Cancer. 2023 Nov;129(11):1787-1792. doi: 10.1038/s41416-023-02388-7. Epub 2023 Oct 20.
Other Identifiers
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NXCEL1311
Identifier Type: -
Identifier Source: org_study_id
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